Switching from Inadequate Adjunctive or Combination Treatment Options to Brexpiprazole Adjunctive to Antidepressant: An Open-Label Study on the Effects on Depressive Symptoms and Cognitive and Physical Functioning.

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Fava M, Okame T, Matsushima Y, Perry P, Weiller E, Baker RA,

Fava M, Okame T, Matsushima Y, Perry P, Weiller E, Baker RA,

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The international journal of neuropsychopharmacology 2016 Oct 26() pii pyw087AbstractBACKGROUND
Approximately 50% of patients with major depressive disorder (MDD) do not respond adequately to their antidepressant treatment (ADT), underscoring the need for more effective treatment options. The objective of this study was to investigate the effect of adjunctive brexpiprazole on depressive symptoms in patients with MDD who were not responding to adjunctive or combination therapy of their current ADTs with several different classes of agents (NCT02012218).

METHODS
In this 6-week, open-label, phase 3b study, patients with MDD who had an inadequate response to ≥1 adjunctive or combination therapy, in addition to history of ≥1 failure to monotherapy ADT, were switched to adjunctive brexpiprazole. Efficacy was assessed by change from baseline to Week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Patient functioning was assessed using Sheehan Disability Scale (SDS) and Cognitive and Physical Functioning Questionnaire (CPFQ). Safety and tolerability were also assessed.

RESULTS
A total of 51/61 (83.6%) patients completed 6 weeks of treatment with adjunctive brexpiprazole. Improvements in depressive symptoms were observed (least squares mean change from baseline to Week 6 in MADRS total score, -17.3 [p<0.0001]) as well as improvements in general and cognitive functioning (mean changes from baseline to Week 6: SDS, -3.1 [p<0.0001]; MGH-CPFQ, -9.2 [p<0.0001]). The most common adverse event was fatigue (14.8%); akathisia was reported by 8.2% of patients.
CONCLUSIONS
In patients with MDD who had switched to open-label adjunctive brexpiprazole following inadequate response to previous adjunctive or combination therapy, improvements were observed in depressive symptoms, general functioning, cognitive function, and energy/alertness.